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Antimicrob Agents Chemother. 2000 April; 44(4): 1114–1115.
PMCID: PMC89828
New Antimicrobial Agents Approved by the U.S. Food and Drug Administration in 1999 and New Indications for Previously Approved Agents
Date of approvalTrade name (form)Generic name(s)ManufacturerIndications or use
5 Jan 99Lamisil (emulsion, cream)Terbinafine hydrochlorideNovartis Pharmaceuticals Corp.Expansion of labeling to include patients with onychomycosis of fingernail or toenail even when associated with nondermatophytes
5 Jan 99Mepron (suspension)AtovaquoneGlaxo Wellcome Inc.For prevention of Pneumocystis carinii pneumonia
22 Jan 99Prevpac (tablet)Amoxicillin, clarithromycin, lansoprazoleTap Holdings Inc.For eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence
9 Mar 99Lamisil (emulsion, cream)Terbinafine hydrochlorideNovartis Pharmaceuticals Corp.For over-the-counter treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum
30 Mar 99Sporanox (injectable)ItraconazoleJanssen Research, Johnson and JohnsonFor treatment of blastomycosis, histoplasmosis and aspergillosis in immunocompromised and nonimmunocompromised patients
15 Apr 99Agenerase (capsule)AmprenavirGlaxo Wellcome Inc.For use in children age 4 and older and in adults in combination with other antiretrovirals for HIV infection
26 May 99Norvir (capsule, solution)RitonavirAbbott LaboratoriesFor treatment of HIV infection in combination with other antiretroviral agents
29 Jun 99Norvir (capsule, soft gelatin)RitonavirAbbott LaboratoriesFor treatment of HIV infection in combination with other antiretroviral agents
30 Jun 99Monistat dual pak (suppository)Miconazole nitrateAdvanced Care ProductsTreatment of vulvovaginal candidiasis
1 Jul 99Videx (tablets, powder for oral solution)DidanosineBristol-Myers Squibb Co.Expansion of the monotherapy indication to provide for use in combination with other antiretroviral agents for treatment of HIV-1 infection
1 Jul 99Zerit (capsules, oral solution)StavudineBristol-Myers Squibb Co.Expansion of the monotherapy indication to provide for use in combination with other antiretroviral agents for treatment of HIV-1 infection
14 Jul 99Omnicef (powder for oral suspension)CefdinirParke Davis, Warner-Lambert Co.For a 5-day dosing regiment (7 mg/kg twice daily) for treatment of acute otitis media
26 Jul 99Relenza (inhalant)ZanamivirGlaxo Wellcome Inc.For treatment of uncomplicated acute illness due to influenza virus in adults and adolescents 12 years and older who have been symptomatic for no more than 2 days
26 Jul 99Lamisil (gel)TerbinafineNovartis Pharmaceuticals Corp.For treatment of tinea cruris
13 Aug 99Cleocin (suppository)Clindamycin phosphatePharmacia and Upjohn Co.For treatment of bacterial vaginosis
24 Aug 99Ceftin (tablet)Cefuroxime axetilGlaxo Wellcome Inc.For treatment of acute bacterial maxillary sinusitis in pediatric patents
21 Sep 99Synercid (injectable)Dalfopristin, quinupristinRhone Poulenc Rorer Pharmaceuticals Inc.For treatment of complicated skin and skin structure infections and for treatment of vancomycin-resistant Entrococcus faecium
27 Oct 99Tamiflu (capsule)Oseltamivir phosphateHoffmann-La Roche Inc.For treatment of uncomplicated acute illness due to influenza infections in adults who have been symptomatic for no more than 2 days
28 Oct 99Videx (tablet, powder for oral solution)DidanosineBristol-Myers Squibb Co.For a new strength as well as allowing a change in dosing interval to once-daily administration in combination therapy for treatment of HIV-1 infection
8 Nov 99Omnicef (capsule)CefdinirParke Davis, Warner-Lambert Co.For a 5-day dosing regimen (300 mg twice daily) for treatment of acute exacerbations of chronic bronchitis
24 Nov 99Viracept (tablet, powder)Nelfinavir mesylateAgouron Pharmaceuticals Inc.For a 1,250-mg twice-daily dosing regimen in combination with other antiretroviral therapies as an alternative to the standard dosing regimen of 750 mg three times daily in combination with other antiretrovirals for treatment of HIV infection
10 Dec 99Avelox (tablet)Moxifloxacin hydrochlorideBayer CorporationFor acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, and uncomplicated skin and skin structure infections
17 Dec 99Tequin (tablet; injectable)GatifloxacinBristol-Myers SquibbFor community-acquired pneumonia; acute bacterial exacerbation of chronic bronchitis; acute sinusitis; uncomplicated skin and skin structure infections; uncomplicated urinary tract infections; complicated urinary tract infections; pyelonephritis; uncomplicated urethral, pharyngeal, and rectal gonorrhea in males; and endocervical, pharyngeal, and rectal gonorrhea in females
17 Dec 99Penlac (solution)CiclopiroxHoechst Marion Roussel Inc.For topical treatment in immunocompetent patients with mild to moderate Trichophyton rubrum onychomycosis of fingernails and toenails without lunula involvement